Sample size: With a 80% power and a significance level of 5%, 450 subjects per group are required to show that treatment with glibenclamide is not considered inferior to treatment with insulin if the frequency of outcome composite does not exceed 25% with glibenclamide, whereas it was 18% with insulin (calculated with a non-inferiority margin of 7% and considering that 20% of patients treated with glyburide and Insulin for change half of the patients accept randomization).